Health TrialsbyHealthPanel

Effects of Substance P on Headache Induction in Healthy Individuals

ConditionHealthy Volunteers Only
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanish Headache Center

About this trial

Substance P is a signaling molecule that has been implicated in the pathogenesis of headache. This study aims to ascertain whether administration of substance P can induce headache in healthy adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 to 65 years of age upon entry into screening

A body weight of 50 to 100 kg

Provision of informed consent prior to initiation of any study-specific activities/procedures.

Disqualifiers

Any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache

Any first-degree relatives with a history of a primary headache disorder, except for infrequent episodic tension-type headache

Any history of moderate to severe traumatic brain injury

Any history of cardiovascular disease, including cerebrovascular diseases

Trial design

Design model

Crossover

Treatments tested in this trial

  • Substance P

    Drug

    The participants will receive a continuous intravenous infusion of 20 mL of substance P (1.5 pmol/kg/min) over 20 minutes.

  • Placebo

    Drug

    The participants will receive a continuous intravenous infusion of 20 mL of placebo (isotonic saline) over 20 minutes.

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Substance PExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Headache

The primary outcome is the difference in the incidence of headache\* between substance P and placebo during the 12-hour observational period after infusion start. \* The intensity of headache is rated by the subject on the 11-point numerical rating scale (0 being no headache, 10 being the worst imaginable headache).

Time frame
12 hours

Secondary outcomes

1

Headache Intensity Scores

The secondary outcome is the difference in the area under the curve for median headache intensity scores between substance P and placebo during the 12-hour observational period after infusion start.

Time frame
12 hours

Other outcomes

1

Dilation of the Superficial Temporal Artery

The difference in area under the curve for relative STA dilation between substance P and placebo from the start of infusion to 2 hours after the infusion.

Time frame
2 hours
2

Blood Flow Velocity in the Middle Cerebral Artery

The difference in area under the curve for change in MCA mean blood flow velocity between substance P and placebo from the start of infusion to 2 hours after the infusion.

Time frame
2 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danish Headache Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: